Career Summary: * Working knowledge of FDA regulations, ISO standards, with the understanding of engineering disciplines and manufacturing. * Specializing in company Quality Management Systems (QMS). Revising the current document management systems and setting up new company wide Document Control Systems from the ground floor and up. * Design Mechanical, Electrical, Printed Circuit Boards and cables. With the ability to understand the complete relationship of schematic, part drawings, assemblies, and bill of materials. * Design product from concept to production release using CAD systems. * Strong analytical working skills with common sense problem solving. Effective team leader/manager. Detail oriented with effective interpersonal and communication skills. * Knowledge and understanding of rules of part number interchangeability, business systems interrelationships, multi-site multi-database BOM structure and interactions, product processes as they relate to manufacturing sites, system hierarchy and control trace ability requirements. Ability to drive business process improvements. Along with product development, manufacturing, global suppliers and partners. * Ability to multi-task projects within a fast paced working environment. * Identify documentation best practices and set-up training as required. * Select, develop, and evaluate all levels of personnel and ensure efficient development. * Manage, develop, and work within cross-functional teams to meet quality company goals. * Create and own project plan including schedule, milestones, dependencies and critical path. * Chair CAPA and CCB meetings facilitate discussions, status, and managing forward progress. COMPANY / WORK HISTORY Company: Karma Automotive - Costa Mesa, California - September, 2016 - April 2017 Responsibilities: Engineering Change Coordinator * Provide superior customer service to Engineers and assigned module groups. * Write clear and concise Engineering Change Requests (ECRs), together with Design Release Engineer and track through system. * Monitor, track, and organize changes of all assigned Module Groups * Troubleshoot and correct all ECR related errors. * Works with Change Management Manager and Leads in the training of Engineer's in Release and Change Management related processes. * Assist Engineering with the creation/update, check-in and linking of documents relevant to a change request. * Assist Engineering to upload preliminary and released data to FTP for supplier review. * Assist Engineering to upload vehicle product data from shared drive or FTP to PDM. * Document notes from Design Reviews and Change Board assuring their accuracy with DRE. * Ensure that only properly described and maintained documents (this includes also EBOM, drawings, CAD models, etc.) are being released or changed. Company: ASP - Irvine, California - September, 2014 - September 2016 Responsibilities: Business Analyst * Planning project timelines and responsibilities. * Manage all aspects of the change control processes to ensure proposed changes comply to defined procedures are fully evaluated, planned, documented and implemented. * Facilitate change orders (CO) through company and regulatory process. * Ensure data integrity of each CO to assure clarity and completeness. * Analyze and evaluate supporting documentation to ensure that each change is effective. * Provide technical direction and consultation to technical support staff or other organizations. * Develop metrics to evaluate the effectiveness and efficiency of the process. * Schedule the Change Control Board meetings (CCB) and prepare the agenda. Chair CCB Meeting and confirm team consensus, resolve outstanding issues. * Promote good documentation practices and proper management of data and records. Provide the Product Development Team with avenues for candid feedback on product change control processes, non-conformance processes and tools. * Design and recommend improvements to team processes, procedures and tools. Company: Velodyne (Consultant) - Morgan Hill, California - 2013 - 2014 Responsibilities: Business Analyst * Manage, develop, and work within cross-functional teams to meet company goals. * Communicate necessary decisions, facilitate problem resolution, and devise process improvements. * Revising the current change control systems, while supporting the old document control system and setting up a new company wide Document Control process. * "https://en.wikipedia.org/wiki/Modular_function_deployment" \o "Modular function deployment" Modular function deployment uses QFD to establish customer requirements and to identify important design requirements with a special emphasis on modularity. * Identify documentation best practices and set-up training as required for each department. * Work with design requirements control the design of the project throughout the engineering design process. * Analyze and create change request packages for accuracy, and completeness. * Design and recommend process improvements to achieve system metrics. * Promote configuration management principles and train others on its importance. * New product development (NPD) covering the complete process of bringing a new "https://en.wikipedia.org/wiki/Product_(business)" \o "Product (business)" product to market. Company: Intuitive Surgical (Consultant) - Sunnyvale California - 2011 - 2013 Responsibilities: Project Manager - Quality Management Systems * Provide weekly communication and coordination with key project stakeholders and Executive Management Project manager in company Quality Management Systems (QMS). * Revising the current QMS and setting up a new company wide QMS from the ground floor and up. Initiate project plans to meet company document control systems objectives. Develop and maintain standard operating procedures and requirements. * Manage internal projects including data migration, and tool development. Analyze and create change request packages for accuracy, and completeness. * Communicate project status and issues to senior management and stakeholders. * Create proactive systems updating schedules to meet current and future requirements. * Lead cross-functional teams to implement and support all requirements for all products. * Maintain product requirements for reusable and disposable instruments, accessories and kits.

Highlights:

• Quality
• Document Control
• Engineering
• Management
• Product Development
• Support
• Autocad
• Autodesk AutoCAD
• Baan
• CAT